Evidence map›Paper›PMID 40779218›Full record

ArticleInternational journal of clinical oncology2025

Post-marketing surveillance of radium-223 chloride in Japanese patients with castration-resistant prostate cancer with bone metastasis-final analysis of 3-year extended follow-up focusing on bone fractures.

Naoya Masumori, Makoto Hosono, Shunji Takahashi, Yoshiyuki Kakehi, Hirotsugu Uemura, Toshiyuki Sunaya, Kako Shimotsumagari, Yasuhiro Matsuba, Masatoshi Adachi, Haruka Kakiuchi and 1 more

Abstract readMulticenter Study
In one paragraph

Article in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Observational
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Naoya MasumoriDepartment of Urology, Sapporo Medical University School of Medicine, S1, W16, Chuo-ku, Sapporo, 060-8543, Japan. masumori@sapmed.ac.jp.
Makoto HosonoDepartment of Radiology, Faculty of Medicine, Kindai University, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
Shunji TakahashiDepartment of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, Japan.
Yoshiyuki KakehiDepartment of Urology, Faculty of Medicine, Kagawa University, 1750-1, Ikenobe, Miki-cho, Kita-Gun, Kagawa, 761-0793, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University School of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
Toshiyuki SunayaClinical Statistics and Analytics Japan, Research Development Japan, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-ku, Osaka, 530-0001, Japan.
Kako ShimotsumagariPMS, Integrated Evidence Generation. Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-ku, Osaka, 530-0001, Japan.
Yasuhiro MatsubaPharmacovigilance Monitoring and Governance, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-ku, Osaka, 530-0001, Japan.
Masatoshi AdachiMedical Affairs Oncology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Haruka KakiuchiMedical Affairs Oncology, Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Seigo KinuyaDepartment of Nuclear Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, 13-1 Takara-Machi, Kanazawa, 920-8641, Japan.

Funding

Astellas Pharma honorariaAstraZeneca KK honorariaAstraZeneca KK research fundingBayer Yakuhin honorariaBayer Yakuhin research fundingBristol-Myers Squibb research fundingChugai Pharmaceutical research fundingDaiichi-Sankyo research fundingEisai honorariaEisai research fundingJanssen Japan honorariaMerck Sharp and Dohme K.K. honorariaMerck Sharp and Dohme K.K. research fundingNovartis research fundingOno Pharmaceutical honorariaOno Pharmaceutical research fundingSanofi K.K. honorariaTaiho Pharmaceutical research fundingTakeda Pharmaceutical Company honoraria
6 · The paper itself

Abstract

backgroundA post-marketing surveillance (PMS) study was conducted in Japan to assess real-world outcomes with radium-223 treatment in men with metastatic castration-resistant prostate cancer (mCRPC). Results from the treatment period showed that radium-223 was generally well tolerated. Follow-up was subsequently extended to 3 years to collect data on fracture events. Results of the extended follow-up are now reported.

methodsThis prospective, non-interventional, multicenter, single-cohort PMS study enrolled men with CRPC and bone metastases treated with radium-223 under clinical practice. Extended follow-up lasted until 3 years after the first administration of radium-223. Data on clinical fractures and survival were collected.

resultsA total of 334 patients were enrolled, with a median follow-up of 15.3 months (range 1-50). The overall incidence proportion of fractures reported as adverse events was 7.76% (95% confidence interval [CI] 5.09-11.25%), with a fracture incidence rate of 5.22 patients [with fracture]/100 person-years (PY). Patients who received bone-modifying agents (BMAs) had a numerically lower incidence of fractures (5.85%; 3.46/100PY vs 9.93%; 7.92/100PY). Median overall survival was 26.32 months (95% CI 21.65-not reached).

conclusionCompared with existing reference data, there was no obvious increase in the incidence of clinical fractures in Japanese patients with mCRPC who were treated with radium-223 under clinical practice. As is already well known for androgen deprivation, BMAs may also be useful in reducing bone fracture after radium-223.

Indexed as

Bone NeoplasmsFractures, BoneProstatic Neoplasms, Castration-ResistantRadiumAgedAged, 80 and overEast Asian PeopleFollow-Up StudiesHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesRadioisotopesRadioisotopesRadiumRadium-223radium Ra 223 dichlorideBone metastasesCastration-resistant prostate cancerJapanese patientsPost-marketing surveillanceRadium-223Real-world data

Identifiers

PMID40779218
PMCPMC12474616

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.